WesleyInman
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A judge sentenced the president of a dietary supplement company to serve 18 months in prison for introducing misbranded food into interstate commerce, the U.S. Justice Department announced this week.
Derek Vest of Gentech Pharmaceutical authorized the use of an amphetamine derivative, DMAA (1,3-Dimethylamine), in various supplements, but he failed to disclose the presence of DMAA on the product labeling for the tablets, according to a July 18 press release from the U.S. Attorney’s Office for the Middle District of Florida.
David Goldberg, an attorney representing Vest, and Lexium International, formerly known as Gentech, did not immediately respond to requests for comment.
FDA for years has maintained DMAA is an illegal ingredient in dietary supplements, and a federal judge sided in April with the public health agency in an unrelated case that is likely to be reviewed by a federal appeals court in Atlanta.
In March, the 52-year-old Vest of Fort Myers, Florida accepted a plea deal following a federal grand jury investigation into his company’s manufacturing, marketing and sales of dietary supplements containing unlabeled DMAA.
Formed in 2010, “Gentech developed and sold supplement products for cognitive function, weight loss and sleep aid," according to a 2016 filing with federal regulators by Lexium. Gentech later changed its name to Lexium, and Vest sold his interest in Lexium in 2015, the filing noted.
The conduct targeted by federal prosecutors covered April 2013 to November 2014 while Vest oversaw the manufacture, marketing and sale of purported dietary supplements as president of Gentech.
During the above period, Vest’s company sold more than 2 million misbranded tablets that were shipped to consumers, the U.S. Attorney’s Office said. Vest must forfeit US$2.5 million as part of his plea deal and the sentence imposed by the court.
Daniel Williams, a spokesman for the U.S. Attorney’s Office in Tampa, Florida, declined a request to interview the prosecutor in the case, Yolande Viacava, regarding Vest’s sentence. However, he said the offense to which Vest pleaded guilty carried a maximum statutory penalty of three years in prison, and the government recommended a sentence at the low end of the advisory guideline range.
“Ultimately, it was the court that determined the sentence that was sufficient, but not greater than necessary, and imposed a sentence of 18 months imprisonment," Williams said in an emailed statement.
Marc Ullman, a lawyer in New York who advises dietary supplement companies on FDA regulations, said the prosecution against Vest “should serve as a reminder that violations of the Federal Food, Drug and Cosmetic Act are all potentially criminal offenses.
“While FDA is often very slow in bringing prosecutions like this, companies need to realize that this is a public health law and that ignoring FDA warnings can come with very severe consequences," said Ullman, Of Counsel to Rivkin Radler LLP, in an emailed statement.
In an unrelated case, a federal judge in April rejected a dietary supplement manufacturer’s argument that DMAA qualifies as a dietary ingredient. Jared Wheat, the owner of Hi-Tech Pharmaceuticals Inc., which has sold supplements containing DMAA for several years, has vowed to file an appeal.
“Our position on DMAA has been constant," Steven Tave, director of FDA’s Office of Dietary Supplement Programs (ODSP), told INSIDER in a phone interview earlier this year. “It’s an illegal ingredient. It shouldn’t be in dietary supplements.
Tave suggested other companies selling DMAA are on FDA’s radar for enforcement action.
“When we see it, we take action," he said, “but … action isn’t necessarily instantaneous, so whether it’s a warning letter, whether it’s judicial action, just because you haven’t seen something happen doesn’t mean that we’re not working on it."
Original Article
https://www.naturalproductsinsider.com/blogs/insider-law/2017/07/executive-sold-dmaa-supplements-sentenced-to-pris.aspx
Derek Vest of Gentech Pharmaceutical authorized the use of an amphetamine derivative, DMAA (1,3-Dimethylamine), in various supplements, but he failed to disclose the presence of DMAA on the product labeling for the tablets, according to a July 18 press release from the U.S. Attorney’s Office for the Middle District of Florida.
David Goldberg, an attorney representing Vest, and Lexium International, formerly known as Gentech, did not immediately respond to requests for comment.
FDA for years has maintained DMAA is an illegal ingredient in dietary supplements, and a federal judge sided in April with the public health agency in an unrelated case that is likely to be reviewed by a federal appeals court in Atlanta.
In March, the 52-year-old Vest of Fort Myers, Florida accepted a plea deal following a federal grand jury investigation into his company’s manufacturing, marketing and sales of dietary supplements containing unlabeled DMAA.
Formed in 2010, “Gentech developed and sold supplement products for cognitive function, weight loss and sleep aid," according to a 2016 filing with federal regulators by Lexium. Gentech later changed its name to Lexium, and Vest sold his interest in Lexium in 2015, the filing noted.
The conduct targeted by federal prosecutors covered April 2013 to November 2014 while Vest oversaw the manufacture, marketing and sale of purported dietary supplements as president of Gentech.
During the above period, Vest’s company sold more than 2 million misbranded tablets that were shipped to consumers, the U.S. Attorney’s Office said. Vest must forfeit US$2.5 million as part of his plea deal and the sentence imposed by the court.
Daniel Williams, a spokesman for the U.S. Attorney’s Office in Tampa, Florida, declined a request to interview the prosecutor in the case, Yolande Viacava, regarding Vest’s sentence. However, he said the offense to which Vest pleaded guilty carried a maximum statutory penalty of three years in prison, and the government recommended a sentence at the low end of the advisory guideline range.
“Ultimately, it was the court that determined the sentence that was sufficient, but not greater than necessary, and imposed a sentence of 18 months imprisonment," Williams said in an emailed statement.
Marc Ullman, a lawyer in New York who advises dietary supplement companies on FDA regulations, said the prosecution against Vest “should serve as a reminder that violations of the Federal Food, Drug and Cosmetic Act are all potentially criminal offenses.
“While FDA is often very slow in bringing prosecutions like this, companies need to realize that this is a public health law and that ignoring FDA warnings can come with very severe consequences," said Ullman, Of Counsel to Rivkin Radler LLP, in an emailed statement.
In an unrelated case, a federal judge in April rejected a dietary supplement manufacturer’s argument that DMAA qualifies as a dietary ingredient. Jared Wheat, the owner of Hi-Tech Pharmaceuticals Inc., which has sold supplements containing DMAA for several years, has vowed to file an appeal.
“Our position on DMAA has been constant," Steven Tave, director of FDA’s Office of Dietary Supplement Programs (ODSP), told INSIDER in a phone interview earlier this year. “It’s an illegal ingredient. It shouldn’t be in dietary supplements.
Tave suggested other companies selling DMAA are on FDA’s radar for enforcement action.
“When we see it, we take action," he said, “but … action isn’t necessarily instantaneous, so whether it’s a warning letter, whether it’s judicial action, just because you haven’t seen something happen doesn’t mean that we’re not working on it."
Original Article
https://www.naturalproductsinsider.com/blogs/insider-law/2017/07/executive-sold-dmaa-supplements-sentenced-to-pris.aspx
